Blood collection container

ABSTRACT

An improved blood collection container having a reduced portion disposed between its closed longitudinal ends and a stopper means disposed therein and adopted under the influence of centrifugal force to be securely received in the reduced portion is described.

United States Patent [1 1 [111 3,786,985 Blaivas Jan. 22, 1974 [5 BLOODCOLLECTION CONTAINER 3,647,070 3/1972 Adler 210/83 3 7 k [75] Inventor:Murray Aaron Blaivas, New York, 5/19 1 PIC ermg 233/1 A X N.Y. FOREIGNPATENTS OR APPLICATIONS Assigneez Hoffman-La Roche Inc Nutley GreatBritain Primary ExaminerGeorge H. Krizmanich [22] Flled 1973 Attorney,Agent, or Firm-Samuel L. Welt; Jon S. [21] Appl. No.: 321,430 Saxe;William G. Isgro [52] U.S. Cl. 233/26 57 ABSTRACT [51] Int. Cl B04b 9/12[58] Field of Search 233/1 A, 1 R 210/83; An improved blood collectioncontainer having a re- 23/292 duced portion disposed between its closedlongitudinal ends and a stopper means disposed therein and 56]References Cited adopted under the influence of centrifugal force to beUNTED STATES PATENTS securely received in the reduced portion isdescribed.

3.508.653 4/1970 Coleman 210/83 1 Claim, 5 Drawing Figures BLOODCOLLECTION CONTAINER DETAILED DESCRIPTION OF THE INVENTION The inventionrelates to an improved container for collecting, stabilizing and storingfor long periods of time a blood specimen and methods therefor. Moreparticularly, the present invention relates to a new and improved vacuumcontainer for collecting and stabilizing blood which comprises acontainer member having one end which may be integrally closed and theother end closed by a plug, a reduced portion disposed between thelongitudinal ends of said container member and a closure means disposedtherein and adopted under the influence of centrifugal force to besecurely received in the reduced portion.

Vacuum-type containers for collecting blood specimens are well known inthe art. In use, such containers comprise a hollow tubular memberprovided with a hypodermic needle which is inserted directly or via acannula into the container. The blood so-obtained, after appropriatetreatment and separation, is tested for physiologically significantindications. For example, the blood sample may be treated with ananticoagulant and centrifuged whereby the plasma is separated from theparticulate matter, i.e. red and white cells and platelets and,thereafter, the plasma can be analyzed utilizing appropriate biochemicaland serological tests. Alternatively, the blood sample may be allowed toclot without prior treatment and then centrifuged whereby the serum isseparated from the particulate matter, and thereafter the serum can beanalyzed utilizing biochemical and serological tests. In both instances,it is important that the liquid portion of the blood, that is, theplasma or serum, be physically separated from the particulate matter toinsure stabilization of the plasma or the serum and, consequently,insure that the data obtained from the biochemical and serological testsaccurately reflects the condition of the patient.

While prior art devices do function efficaciously to obtain bloodsamples, they require that the collected sample be promptly analyzed dueto the fact that upon standing blood deteriorates, i.e. its constituentsinteract and thereby causes inaccurate analysis. Thus, prior art devicessuffer from the defect of lacking means for preventing blooddeterioration from occurring, that is, means which insure stabilization,if the blood sample is permitted to stand for extended periods of time.

As is known, a breakdown of the components of blood will occur if bloodis permitted to stand for a period of time. The major cause of suchdeterioration can be attributed to the biochemical makeup of the bloodsample and particularly the interaction between plasma or serum and thecellular portion of the blood, that is, the particulate matter found inblood. If biochemical changes occur in the sample, inaccurate analyseswill result. Prompt separation of plasma or serum serum content of thespecimen sample long after the blood sample has been collected.

Accurate diagnosis of a blood sample for physiological indications isindeed of critical importance in assuring proper medical care to thepatient. In many circumstances, however, the patient is removed from thelaboratory facilities which possess the capability of performingaccurate multiple analysis of the sample. Thus, the transmittal of thesample to the laboratory for analysis thereof inherently presentsproblems.

It is an object of the present invention to provide the art with a bloodcollecting and stabilizing container and a method which assures thestabilization of blood even after the sample has been stored for longperiods of time.

It is another object of the present invention to provide in a singleapparatus means for collecting a blood sample and means for separatingthe liquid portion of blood from its particulate matter.

It is a further object of the present invention to furnish an apparatuswhich will include relatively few parts and which is capable of readyand economical manufacture.

It is a still further object of the present invention to provide amethod performable on a conventional centrifugal machine.

In achieving the objects of the present invention, an evacuated tubularcontainer made of suitable material,

preferably glass or plastic, is provided with a section which is taperedto provide a reduced tapered portion intermediate its end, preferably,no more than mid-way down the upper end of the tubular container. Afterblood is collected, the vessel is subject to varying centrifugal forces.Under the influence of a lower centrifugal force, the plasma or serumseparates from the particulate matter. Thereafter, a deformable memberpositioned in the container is moved under the influence of a highercentrifugal force to a position whereby it is securely received in saidtapered position. In this position, the deformable member is positionedbetween the portions of the container which contains, respectively, theplasma or serum and the particulate matter. In this manner, the plasmaor serum remain separated and contact with the particulate matter isavoided.

The centrifugal force required to move the deformable member and toseparate the plasma or the serum from the particulate matter is providedby any conventional centrifuge. Physicians, laboratory technicians andthe like use centrifuges to spin or whirl containers or vesselscontaining blood sample to subject the sample to centrifugal force. Suchdevices usually consist of a rotor adopted to spin about a horizontalplane. The machine is equipped with a series of elongated recepticlespivotally mounted near the open ends so as to depend vertically when therotor is at its rest position. The lower portions of the recepticles areadopted to swing outwardly and upwardly to bring the recepticlessubstantially radially upon rotation of the rotor. The recepticles ofthe centrifugal machine are loaded with the sample containing vessels bydropping the latter therein while the recepticles rest in dependingpositions. Such centrifugal devices can be activated so that the rotorcan rotate at varying speeds. As should be evident, such machines arewell known in the art.

For a full understanding of the nature and objects of the invention,reference should be had to the following detailed description taken inconnection with the accompanying drawings in which:

FIG. 1 is a side view with parts in cross section of an apparatusembodying the invention before use;

FIG. 2 is a side view with parts in cross section of an apparatusembodying the invention showing transition of the closure means withrespect to the reduced poron of h ssn riqa-.-

FIG. 3 is a side view in cross section of an embodiment of the closuremeans of the apparatus of the inn i no a- FIG. 4 is a side view withparts in cross section of an apparatus embodying the invention afteruse; an d FIG. 5 is a side view with parts in cross section of anotherapparatus embodying the invention before use.

Referring now to the drawings and particularly to FIG. 1, a tubularmember, vessel or container formed from any suitable material,preferably, glass or plastic, is provided with an open end 11 and areduced intermediate section 17. I u 7 A stopper 13 is removablyreceived in the open end 1 1. The stopper 13 is made of rubber or anyother suitable composition. The stopper 13 may be provided with a needlemeans not shown. The tubular member 10 is evacuated so that upon releaseof the vacuum, blood from a patient can be drawn into the tubular memberin accordance with conventional techniques. Evacuation may be effectedby passing an evacuating means through the stopper l3 and closure means30 which evacuating means isconnccted to an evacuating mechanism.

The tubular member, vessel or container 10 comprises two sections 20 and21 and a reduced portion 17 which are integrally connected. Section 20extends from end 11 which is closed by stopper 13 to the reduced portion17. Section 20 includes a tapered portion 23. Section 21 extends fromclosed end 25 to the reduced portion 17 and includes tapered portion 24.The reduced portion 17 is positioned at the juncture of tapered portions23 and 24. As can be seen from FIG. 1, theopening defined by reducedportion 17 and by the inner walls of tapered portion 23 and 24 is of adiameter which is less than the diameter of the opening defined by thelongitudinal walls of the vessel 10 which are not tapered.

In another embodiment of the invention, as shown in FIG. 5, in tubularmember, vessel or container 10, the longitudinal walls of section 20 aretapered so that the diameter of the opening defined by the upper end ofsection 20' opposite to closure member 30 is smaller than the diameterof the opening defined by the lower end of section 20' nearer to reducedportion 17, and the opening defined by reduced portion 17 and by theinner walls of tapered portions 23 and 24 are of a diameter which isless than the diameter of the opening defined by the upper end ofsection 20' opposite closure member 30.

Referring still to F l6. 1 but now including FIG. 3 disposed withinsection 20 is closure means 30 which may be of rubber, plastic or othersuitable elastomeric deformable material. The closure means 30 comprisesa tapered body portion 31 which centrally defines a diaphragm 32. Thecontiguous outer wall of said tapered body portion is adapted to engagethe upper end of the inner surface of section 20 below stopper 13. Thetapered body portion 31 of closure means 30 should be so sized that theupper portion thereof 34 will bear against the adjacent inner wall ofvessel 10 and not move toward the reduced portion 17 under normalconditions or under the influence of a centrifugal force which willcause separation of the plasma or the serum from the particulate matter.

Extending downwardly from diaphragm 32 is a deformable tapered portion33. When in deformed condition, the configuration of tapered portion 33conforms to the tapered portion 23 of section 20.

In accordance with this invention, container 10 should be constructed sothat preferably the total volume contained within section 20 isapproximately 40 percent of the total volume contained within the entiretube. Hence, the volume contained within section 21 is approximately 60percent of the total volume contained in the entire tube.

In operation, blood is collected in the evacuated container according toconventional procedures, by puncturing simultaneously the stopper 13 andthe diaphragm 32 of closure means 30. The container is then placed on acentrifuge of conventional design. Upon centrifuging at lower speeds,e.g., from about 1,500 RPM to 3,000 RPM, the serum or plasma isseparated from the particulate matter with the serum or plasma beingreceived in section 20 and particulate matter being received in section21. After separation of the serum or the plasma from the particulatematter, the speed of the centrifuge is increased, preferably to abouttwice the speed employed to separate the plasma or the serum, however,speeds from about 2,500 RPM to about 4,000 RPM should be sufficient. Asshown in FIG. 2, the tapered end 33 of the closure means 30 is driventoward the reduced orifice 17 under the influence of the increasedcentrifugal force until it is wedged into tapered portion 23 as seen inFIG. 4. Thus, the plasma or the serum is permanently separated from theparticulate and cross-reaction of one with the'other is precluded.

The device in FIG. 2 is shown as being under the influence of anincreased centrifugal speed. At this speed, the closure means 30 hasbegun its downward path toward the tapered portion 17. Under theinfluence of the increased centrifugal force, as depicted by thedownwardly extending arrow in FIG. 2, the closure means 30 is deformedthereby permitting fluid to pass between its sides and the inner wallsof section 20, as represented by the upwardly directioned arrows.

Thus, deterioration of the plasma or the serum caused by contact withblood cells or platelets after blood is removed from the human body isavoided. Also, the blood can be stored for long periods of time withoutdegradation or biochemical changes occurring.

By proceeding in this simple manner utilizing readily availableequipment, blood specimen samples can be withdrawn from the patient andthe sample separated and stabilized into serum or plasma. Afterseparation, the sample, can be transmitted to a laboratory where propertesting thereof can be undertaken. Blood specimen transmitted in thisfashion yield accurate data for diagnostically significant parameters.Additionally, the device or apparatus of the present invention providesa simple means for withdrawing, collecting, stabilizing, andtransmitting blood samples without the necessity of utilizing separatedevices. In this manner, the aseptic transfer of blood is accomplishedin one apparatus without having to transfer the blood into separatedevices or containers thereby subjecting the blood to additional sourcesof contamination by exposure to the atmosphere.

Particularly noteworthy is also the fact that blood exposed to theatmosphere even for short periods of time will rapidly deteriorate. Byutilizing the device which is the present invention, it is assured thatthe serum or the plasma are separated under aseptic conditions.

I claim:

1. A method for stabilizing a blood sample after collection in a hollowcontainer, which container comprises two closed ends connected byelongated sides, said sides having formed therein a reduced portionwhich extends inwardly into the interior of the hollow container, saidcontainer including a movable elastomeric closure means disposed in theinterior of the hollow container between one of said closed ends inclose proximity to the last-mentioned closed end and the reducedportion, such closure means having a deformable end extending toward thereduced portion, the other end of the closure means under normalconditions being in resilient engagement with the inner walls of saidsides, which comprises (1) centrifuging said container at a speed thateffects separation of the blood sample contained therein into twodiscrete phases, one phase consisting predominantly of the liquidconstituent of the blood sample and the other consisting predominantlyof the particulate phase; (2) increasing the centrifugal speed, to aspeed which causes movement of the resilient member toward the reducedportion; and (3) centrifuging at such rate until the deformable end issecurely received in the reduced portion.

1. A method for stabilizing a blood sample after collection in a hollowcontainer, which container comprises two closed ends connected byelongated sides, said sides having formed therein a reduced portionwhich extends inwardly into the interior of the hollow container, saidcontainer including a movable elastomeric closure means disposed in theinterior of the hollow container between one of said closed ends inclose proximity to the lastmentioned closed end and the reduced portion,such closure means having a deformable end extending toward the reducedportion, the other end of the closure means under normal conditionsbeing in resilient engagement with the inner walls of said sides, whichcomprises (1) centrifuging said container at a speed that effectsseparation of the blood sample contained therein into two discretephases, one phase consisting predominantly of the liquid constituent ofthe blood sample and the other consisting predominantly of theparticulate phase; (2) increasing the centrifugal speed, to a speedwhich causes movement of the resilient member toward the reducedportion; and (3) centrifuging aT such rate until the deformable end issecurely received in the reduced portion.